Privacy and security, patient safety, a clear legal framework and better evidence on cost-effectiveness are all required to help mobile Health care ('mHealth') flourish in Europe, according to the responses to a European Commission public consultation published today.

211 separate responses from public authorities, healthcare providers, patients' organisations and web entrepreneurs, inside and outside the EU, gave feedback on eleven issues related to the uptake of mHealth in the EU. While recent statistics confirm that national and EU funding initiatives are bearing fruit and that Europe is set to become the largest market by 2018, responses indicated that more remains to be done so that EU entrepreneurs can effectively access this booming market.

97 respondents believe that strong privacy and security tools (such as data encryption and authentication mechanisms) are needed to build users' trust. Half of the respondents called for a strengthened enforcement of data protection and the rules applicable to mHealth devices.

Nearly half of the respondents ask for more patient safety and transparency of information, by means of certification schemes or quality labelling of lifestyle and wellbeing apps. Nevertheless, some warn against the risks of over-regulation.

Web entrepreneurs consider it difficult to access the market due to the lack of a clear regulatory framework, interoperability and common quality criteria.

71 respondents think performance and safety requirements and liability rules applicable to lifestyle and wellbeing apps should be clarified, through legislation, self-regulation or guidance.

A fifth of respondents believe more evidence is needed on the cost-effectiveness of mHealth. 21 respondents referred to specific studies and projects which have demonstrated efficiency gains. For example, according to one study, trials in the Nordic countries have shown that mHealth could generate a 50-60% reduction in hospital nights and re-hospitalization for patients with Chronic Obstructive Pulmonary Disease. The same study estimates that mHealth could reduce overall elderly care expenditure by 25%.

Respondents also suggested that:

EU and national actions should ensure interoperability of mHealth solutions with Electronic Health Records (EHRs) for continuity of care and for research purposes.

Greater emphasis should be put on actions to promote open standards and the use of the common open architecture or open Application Programming Interfaces.

Health professionals, care-givers and users should be actively involved in co-designing mHealth solutions.

Next steps

The Commission will, in the course of 2015, discuss with stakeholders the options for policy actions (legislation, self- or co-regulation, policy guidelines, etc.).

A series of actions to support mHealth deployment are already foreseen under Horizon 2020 and will be taken into account in future work programmes. mHealth will be one of the key topics on the agenda of eHealth Week in Riga in May 2015.

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